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DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial registered on ANZCTR
Registration number
ACTRN12619000771156
Ethics application status
Approved
Date submitted
14/05/2019
Date registered
23/05/2019
Date last updated
22/03/2021
Date data sharing statement initially provided
23/05/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Co-creating and evaluating an online self-help treatment (iSelf-help) for people with persistent pain
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Scientific title
Clinical and cost-effectiveness of an online delivered group-based pain management programme (iSelf-help) in improving pain-related disability for people with persistent pain - A non-inferiority randomised controlled trial
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Secondary ID [1]
298169
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None
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Universal Trial Number (UTN)
U1111-1215-5284
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Trial acronym
iSELFHELP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Persistent non-cancer pain
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persistent primary pain
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persistent secondary pain
312730
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Condition category
Condition code
Anaesthesiology
311230
311230
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0
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Pain management
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The 12-week group-based online-intervention (iSelf-help) will be delivered via an online smartphone application and a password-protected website.
iSelf-help: The iSelf-help has been co-designed with patients with persistent pain and Maori living with persistent pain and their whanau to ensure cultural appropriateness. The iSelf-help consists of 12 online modules similar to in-person pain management programme (PMP).
The 12 modules of iSelf-help are: 0) Welcome to Pain management programme, 1) Exercise, 2) Sensory nervous system, 3) Stress response, 4) Think, feel, do, 5) Memory of pain, 6) Taking charge, 7) Thinking and doing skills, 8) Medication, 9) Sleep, 10) Making plans with pain, 11) Sharing the journey, 12) Pulling it all together
Resources: Each module consists of a short introductory video (30s), educational video by a pain management clinician (5mins), videos of patient stories sharing their experiences of managing pain and associated symptoms relevant to the module, relaxation podcasts and additional resources such as animations, illustrated texts and links of additional resources.
Each module of iSelf-help will be made available to the participants at the beginning of each week. Participants are asked to use these resources at their own time.
In addition, the iSelf-help arm with 8 to 12 participants/group at baseline will receive two, 60-minute sessions weekly for 12 weeks.
One 60-minute session/week will be delivered via an online self-management platform by a dedicated pain management clinician (physiotherapist) of our research team. Each session comprises education (30mins), advice on guided exercises (15mins) and relaxation techniques (15mins). Education sessions are likely to focus on knowledge and Cognitive Behavioural Therapy-based self-management skills (e.g. pain education, activity pacing, relaxation, and distraction techniques) similar to in-person PMP. Participants are asked to attend the first session and any of the 5 sessions from the remaining 11 weeks.
Later in the same week, the second 60-minute session is likely to be an interactive online closed-group discussion moderated by a health coach (e.g. a trained volunteer from patient advisory group). The group discussion will focus on self-reflection, goal setting, and the sharing of experiences with peers about what went well, and what did not, over the week and developing peer support network. Participants are asked to attend these discussions at their own discretion.
Peer interaction: The community page of iSelf-help will provide opportunities for peer-interaction throughout the 12-week period. Acommunity manager (personnel with a health background) will monitor the page for safety of posts shared by participants.
Tracking: There will be opportunites for participants to track their exercise, mood level and thought diaries with reminders and nudges to encourage continued use of iSelf-help through the 12-week period.
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Intervention code [1]
314473
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Behaviour
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Intervention code [2]
314534
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Rehabilitation
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Comparator / control treatment
Pain service site #1: The usual care arm with 8 to 12 patients/group at baseline will attend one 180-minute session/week over 12 weeks at Wellington, which is the current delivery model. Each session comprises weekly review (15 mins), two education sessions (45 mins each), group exercise (45 mins), relaxation (20 mins), and a debrief session (10 mins). Weekly education modules focus on a range of self-management strategies (e.g. pain education, CBT, activity scheduling) as delivered by pain management service clinicians.
Pain service site #2: All patients referred to pain management service in Christchurch will be invited to a Burwood Advancement, Screening and Education programme (BASE) educational seminar (7-hours in duration). BASE seminar involves chronic pain education and overview of self-management principles. On completing the BASE seminar and based on psychometric scores, patients are classified as having mild, moderate or high needs. Those classified with mild and moderate needs will be referred to attend the Burwood Pain Self-management Programme (BPSM). BPSM is an in-person delivered, 120-minute group-based session/week over 5 weeks. Each session comprises weekly review (15 mins), relaxation (15 mins), group exercises (40 mins), problem solving techniques for common difficulties associated with persistent pain such as sleep, flare-ups, communication, maintenance, and stress (30 mins) and a goal setting/trouble shooting session (30 mins).
As part of usual practice, the pain management service clinicians in both sites continually reflect after every in-person PMP session and following every cohort and take feedback from patients to adapt and improve their in-person delivery.
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Control group
Active
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Outcomes
Primary outcome [1]
320059
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Pain related disability using modified Roland Morris Disability Questionnaire (RMDQ)
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Assessment method [1]
320059
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Timepoint [1]
320059
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Baseline. immediately after intervention (after 12 weeks), and 3 and 6 months post intervention.
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Secondary outcome [1]
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Anxiety, Depression, Stress using Depression, Anxiety, Stress Scale (DASS-21)
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Assessment method [1]
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Timepoint [1]
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Baseline. immediately after intervention (after 12 weeks), and 3 and 6 months post intervention.
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Secondary outcome [2]
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Pain Severity and pain-related interference using Brief Pain Inventory (BPI) short form
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Assessment method [2]
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Timepoint [2]
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Baseline. immediately after intervention (after 12 weeks), and 3 and 6 months post intervention.
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Secondary outcome [3]
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Quality of life using EQ-5D-5L, five dimensions with five levels of severity
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Assessment method [3]
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Timepoint [3]
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Baseline. immediately after intervention (after 12 weeks), and 3 and 6 months post intervention.
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Secondary outcome [4]
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Acceptance using Chronic pain acceptance questionnaire (CPAQ)
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Assessment method [4]
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Timepoint [4]
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Baseline. immediately after intervention (after 12 weeks), and 3 and 6 months post intervention.
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Secondary outcome [5]
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Self-efficacy using Pain Self-efficacy Questionnaire (PSEQ)
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Assessment method [5]
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Timepoint [5]
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Baseline. immediately after intervention (after 12 weeks), and 3 and 6 months post intervention.
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Secondary outcome [6]
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Catastrophising using Pain Catastrophising Scale (PCS)
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Assessment method [6]
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Timepoint [6]
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Baseline. immediately after intervention (after 12 weeks), and 3 and 6 months post intervention.
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Secondary outcome [7]
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Self-as-Context using Self-Experience Questionnaire (SEQ)
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Assessment method [7]
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Timepoint [7]
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Baseline. immediately after intervention (after 12 weeks), and 3 and 6 months post intervention.
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Secondary outcome [8]
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Fear of movement and reinjury - TAMPA Scale of Kinesiophobia (TSK-11)
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Assessment method [8]
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Timepoint [8]
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Baseline. immediately after intervention (after 12 weeks), and 3 and 6 months post intervention.
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Secondary outcome [9]
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Healthcare use - Adapted from TiC-P questionnaire
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Assessment method [9]
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Timepoint [9]
370394
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Baseline. immediately after intervention (after 12 weeks), and 3 and 6 months post intervention.
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Secondary outcome [10]
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Current medications - Bespoke tool evaluating the use of prescription and over-the-counter pain, pain-related, antidepressant, and anxiolytic medications
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Assessment method [10]
370395
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Timepoint [10]
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Baseline. immediately after intervention (after 12 weeks), and 3 and 6 months post intervention.
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Secondary outcome [11]
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Adherence to iSelf-help (Frequency and duration of website usage, Monitoring the participation in weekly interactive online group discussions)
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Assessment method [11]
370396
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Timepoint [11]
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During 12-week intervention period and till 6 months.
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Secondary outcome [12]
370397
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Acceptability of iSelf-help (Customised questionnaire)
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Assessment method [12]
370397
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Timepoint [12]
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At 12-weeks post intervention
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Secondary outcome [13]
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Satisfaction of iSelf-help (customised questionnaire)
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Assessment method [13]
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Timepoint [13]
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At 12-weeks post intervention
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Eligibility
Key inclusion criteria
People with persistent, non-cancer pain referred for pain management at a tertiary pain management service from the lower half of the North Island and the upper half of the South Island, New Zealand,
Participants with any of the following persistent pain conditions will be included in the study:
• Persistent primary pain,
• Persistent musculoskeletal pain
• Persistent posttraumatic and postsurgical pain
• Persistent neuropathic pain,
• Persistent headache and orofacial pain
• Persistent visceral pain.
Inclusion criteria
(1) Adults with persistent non-cancer pain (defined above) aged 18 years and older,
(2) With daily access to a computer/smartphone at home, workplace or in a public location,
(3) Currently not experiencing any significant uncontrolled mental health condition
(4) Able to provide written informed consent.
We will provide internet subscription for the study period for those without internet access.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
(1) Participants with severe depression defined as >20 from the 7 items of Depression subscale of Depression, Anxiety, Stress Scale (DASS-21)53 and based on clinical evaluation by CCDHB pain management service.
(2) Primary cancer-related pain
(3) Planned surgical intervention for pain
(4) Concurrent participation in an additional multi-disciplinary group based pain management programme
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
To ensure concealed allocation, a research team member will hold the randomisation sequence in sequentially numbered opaque sealed envelopes and will provide envelopes sequentially to the research assistant (outcome assessor) at the end of baseline assessment. Thus, the research assistant will be blinded to the allocation sequence, and the Assistant Research Fellow will ensure the envelopes are opened in the correct order.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will then be block randomised (1:1) in to iSelf-help (intervention) and in-person (usual care) PMP groups with stratification by ethnicity (Maori or non-Maori) to ensure that both arms are similar in terms of ethnicity. The randomisation program (randomizer.org) will be used to generate a randomisation sequence in advance by our research team member not involved in recruitment, assessment or statistical analysis.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Sample size estimation
Trial sample size was calculated based on providing 80% power to detect non-inferiority using a 95% one-sided confidence interval. The margin for non-inferiority was a 3 points difference in changes (the minimal clinically important change) on the RMDQ scale and assuming no actual difference in changes between the two groups (iSelf-help and in-person PMP). The standard deviation for changes in RMDQ was calculated from data reported in a previous trial[51] of 471 participants with 397 excluding the wait-list control group. The standard deviation at baseline for RMDQ was approximately 5.0 (4.8–5.2 over the 4 groups), slightly higher at 3 months being around 5.7 (5.4–5.9 over the 3 groups with follow-up), and with correlations over 3 months of around r=0.5 (estimated from reported data to be 0.44–0.57 over the 3 groups with follow-up), giving an estimated standard deviation for changes of 5.4, which we have used for the six month changes here given the conservative rounding at each stage of the calculations. Allowing for a mean of 10 participants per group at baseline and a loss of 20% over the six months, i.e. a mean of 8 participants per group at follow-up, with an ICC of 0.1 for RMDQ changes, design effects at follow-up are conservatively estimated to be 1.7. A total of n=70 participants would be needed in each group at six months follow-up. To allow for the approximately 20% loss to follow-up, n=90 (across 9 groups) will be recruited into each arm of the study at baseline (n=180), that is 18 groups of 10 in total.
Statistical analyses
Baseline demographic and clinical characteristics will be described for participants in both groups. Linear mixed models will be used to model continuous outcomes (including RMDQ scores) collected over time (baseline, 12 weeks, 3 months, and 6 months) with random effects for participants and groups to accommodate the clustered data. No additional clustering for the two centres will be incorporated in analyses. For each model, an unstructured covariance matrix (and possibly other plausible structures if these are justified by theoretical considerations) for the longitudinal data will be investigated as an alternative to compound symmetry with positive correlations, with selection based on Bayesian Information Criterion values. Marginal and conditional residuals will be investigated to ensure model assumptions are sufficiently well satisfied and natural logarithmic transformations of dependent variables investigated to see if this improves meeting these assumptions. If model assumptions cannot be sufficiently well satisfied through such transformations, quantile mixed models will be used for analyses instead, modelling medians. For count outcomes (including health care use), Poisson or, if there is overdispersion, negative binomial mixed models will be used. Zero-inflated models will be considered if there is an excess of zero values. All models will include the stratification variable (Maori ethnicity). For any missing data, multiple imputation through chained equations and using forms of regression appropriate to the missing variables will be used for the main analyses (with additional analyses based on available data used to investigate the robustness of findings). Pattern-mixture models will be used to explore plausible scenarios of informative missingness. The primary analysis will be guided by intention-to-treat principles to address the effectiveness question, but a secondary analysis will investigate the per protocol efficacy question for those attending at least 70% of their sessions. Success for the intervention will be demonstrated by non-inferiority in changes of RMDQ at 6 months for the effectiveness question. Statistical analyses will be conducted using R 4.0.2 (or later) with two-sided p<0.05 used for statistical significance and one-sided 95% confidence intervals used for non-inferiority.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
24/05/2019
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Actual
7/06/2019
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Date of last participant enrolment
Anticipated
3/09/2021
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Actual
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Date of last data collection
Anticipated
11/02/2022
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Actual
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Sample size
Target
180
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Accrual to date
45
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Final
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Recruitment outside Australia
Country [1]
21478
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New Zealand
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State/province [1]
21478
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Wellington and Christchurch
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Funding & Sponsors
Funding source category [1]
302704
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Government body
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Name [1]
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Health Research Council
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Address [1]
302704
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PO Box 5541, Wellesley Street, Auckland 1141
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Country [1]
302704
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New Zealand
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Primary sponsor type
Individual
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Name
Prof Leigh Hale
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Address
325 Great King Street, School of Physiotherapy,
University of Otago, Dunedin 9016
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Country
New Zealand
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Secondary sponsor category [1]
302712
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Individual
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Name [1]
302712
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Dr Hemakumar Devan
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Address [1]
302712
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23 Mein Street, School of Physiotherapy
University of Otago, Wellington 6242
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Country [1]
302712
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New Zealand
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Secondary sponsor category [2]
302713
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Individual
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Name [2]
302713
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Dr Meredith Perry
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Address [2]
302713
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23 Mein Street, School of Physiotherapy
University of Otago, Wellington 6242
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Country [2]
302713
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New Zealand
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Other collaborator category [1]
280691
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Individual
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Name [1]
280691
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Assoc Prof Rebecca Grainger
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Address [1]
280691
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23 Mein Street, Department of Medicine
University of Otago, Wellington 6242
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Country [1]
280691
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New Zealand
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Other collaborator category [2]
280692
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Individual
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Name [2]
280692
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Prof Edward Shipton
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Address [2]
280692
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University of Otago,
2 Riccarton Avenue
Christchurch Central
Christchurch 8011
New Zealand
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Country [2]
280692
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New Zealand
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Other collaborator category [3]
280693
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Individual
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Name [3]
280693
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Prof Anthony Dowell
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Address [3]
280693
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23 Mein Street, University of Otago, Wellington, 6242
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Country [3]
280693
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New Zealand
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Other collaborator category [4]
280694
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Individual
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Name [4]
280694
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Dr Tristram Ingham
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Address [4]
280694
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23 Mein Street, University of Otago, Wellington, 6242
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Country [4]
280694
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New Zealand
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Other collaborator category [5]
280695
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Individual
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Name [5]
280695
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Ms Bernadette Jones
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Address [5]
280695
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23 Mein Street, University of Otago, Wellington, 6242
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Country [5]
280695
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New Zealand
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Other collaborator category [6]
280696
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Individual
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Name [6]
280696
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Mr William Leung
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Address [6]
280696
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23 Mein Street, University of Otago, Wellington, 6242
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Country [6]
280696
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New Zealand
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Other collaborator category [7]
280697
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Individual
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Name [7]
280697
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Mr Andrew Gray
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Address [7]
280697
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Dean's Department,
Dunedin School of Medicine
Division of Health Sciences
Room 123, Adams Building, 18 Frederick Street, Dunedin 9016
New Zealand
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Country [7]
280697
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New Zealand
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Other collaborator category [8]
280698
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Individual
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Name [8]
280698
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Ms Barbara Saipe
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Address [8]
280698
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Wellington Regional Hospital
Private Bag 7902
Wellington 6242
New Zealand
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Country [8]
280698
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New Zealand
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Other collaborator category [9]
280699
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Individual
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Name [9]
280699
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Ms Dagmar Hempel
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Address [9]
280699
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Wellington Regional Hospital
Private Bag 7902
Wellington 6242
New Zealand
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Country [9]
280699
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New Zealand
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Other collaborator category [10]
280700
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Individual
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Name [10]
280700
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Ms Cheryl Davies
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Address [10]
280700
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Kokiri Marae
7-9 Barnes St,
Seaview,
Lower Hutt 5010
New Zealand
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Country [10]
280700
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New Zealand
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Other collaborator category [11]
280701
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Individual
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Name [11]
280701
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Prof Sarah Dean
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Address [11]
280701
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College House, University of Exeter,
St Luke's Campus,
Heavitree Road, Exeter, EX1 2LU, UK
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Country [11]
280701
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United Kingdom
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303314
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Health and Disability Ethics Committee (HDEC)
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Ethics committee address [1]
303314
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Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
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Ethics committee country [1]
303314
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New Zealand
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Date submitted for ethics approval [1]
303314
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06/09/2018
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Approval date [1]
303314
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20/09/2018
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Ethics approval number [1]
303314
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18/CEN/162
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Summary
Brief summary
The iSelf-help trial is a pragmatic, multi-centred, assessor-blinded, randomised, two-arm, parallel group, non-inferiority study to compare the effectiveness of group-based, online-delivered pain management programme (iSelf-help) as compared to group-based in-person delivered pain management programme in reducing pain-related disability at 6-months. We hypothesise that group iSelf-help will not be less effective than an in-person group PMP.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
93238
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Prof Leigh Hale
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Address
93238
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325 Great King Street, School of Physiotherapy,
University of Otago, Dunedin 9016
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Country
93238
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New Zealand
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Phone
93238
0
+64 34795425
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Fax
93238
0
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Email
93238
0
[email protected]
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Contact person for public queries
Name
93239
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Dr Hemakumar Devan
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Address
93239
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School of Physiotherapy, University of Otago,
PO Box 7343, Newtown, Wellington, 6242
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Country
93239
0
New Zealand
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Phone
93239
0
+64 43855566
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Fax
93239
0
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Email
93239
0
[email protected]
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Contact person for scientific queries
Name
93240
0
Dr Hemakumar Devan
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Address
93240
0
School of Physiotherapy, University of Otago,
PO Box 7343, Newtown, Wellington, 6242
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Country
93240
0
New Zealand
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Phone
93240
0
+64 43855566
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Fax
93240
0
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Email
93240
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Individual participant data of published results only
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When will data be available (start and end dates)?
Start date: 2/01/2023 (After publication)
No End date
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Available to whom?
Only to researchers in this area
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Available for what types of analyses?
Only to achieve the aims in the approved proposal
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How or where can data be obtained?
By emailing the project manager and one of the lead researchers,
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
2082
Informed consent form
[email protected]
377545-(Uploaded-14-05-2019-11-51-41)-Study-related document.doc
2088
Other
[email protected]
Overview of contents of iSelf-help
377545-(Uploaded-14-05-2019-11-52-14)-Study-related document.pdf
2089
Ethical approval
[email protected]
Ethical approval letter
377545-(Uploaded-14-05-2019-11-52-50)-Study-related document.pdf
2091
Other
[email protected]
Overview of contents of in-person pain management ...
[
More Details
]
377545-(Uploaded-14-05-2019-12-01-02)-Study-related document.doc
11118
Study protocol
[email protected]
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Clinical and cost-effectiveness of an online-delivered group-based pain management programme in improving pain-related disability for people with persistent pain - Protocol for a non-inferiority randomised controlled trial (iSelf-help trial).
2021
https://dx.doi.org/10.1136/bmjopen-2020-046376
N.B. These documents automatically identified may not have been verified by the study sponsor.
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